Biomarker discovery & initial steps toward validation / commercialization, relating to diagnostic tests for early detection of Sepsis

Private consulting in the area of IVD / CDx development & validation, design control, risk analysis, software validation. Contracts with ImmuneXpress (Seattle), Pacific Nanoscience (Portland).

Projects involved IVD assays in the cancer diagnostics area. Worked on three separate PMAs for companion diagnostic tests, which were intended for use with oncology drugs for hematologic and solid tissue tumors. Focus was on requirements specification, design control, risk analysis, analytical & clinical validation, software design and software validation.

Private consulting in the area of IVD Development. Contracts with ArcticDx (Toronto ON), Xagenic (Toronto ON), MolecularMD (Portland OR)

In this position I worked on developing genotyping assays (Cystic Fibrosis, CYP 2D6, Ashkenazi Jewish Panel), and pathogen detection assays (respiratory viruses, gastrointestinal pathogens). I was an integral member of teams that successfully obtained FDA clearances for Cystic Fibrosis genotyping (K060627, K083845, K083846), CYP2D6 genotyping (K093420), detection of a panel of respiratory viruses (K063765, K091667), and detection of a panel of GI pathogens (K121454). Responsibilities included… Show more In this position I worked on developing genotyping assays (Cystic Fibrosis, CYP 2D6, Ashkenazi Jewish Panel), and pathogen detection assays (respiratory viruses, gastrointestinal pathogens). I was an integral member of teams that successfully obtained FDA clearances for Cystic Fibrosis genotyping (K060627, K083845, K083846), CYP2D6 genotyping (K093420), detection of a panel of respiratory viruses (K063765, K091667), and detection of a panel of GI pathogens (K121454). Responsibilities included design control, risk analysis, validation studies, statistical analysis. Show less

In my QA role, I was responsible for the initial setup of a Quality System according to the ISO-9001 model. I also set up a small pilot manufacturing facility, developed chain-of-custody procedures for sample handling, and conducted internal quality audits. In my Product Development role, I worked on converting discovery phase biomarkers for various diseases (osteoarthritis, bipolar disorder, and colorectal cancer) into RT-PCR based RNA expression assays, and on pre-clinical validation of these… Show more In my QA role, I was responsible for the initial setup of a Quality System according to the ISO-9001 model. I also set up a small pilot manufacturing facility, developed chain-of-custody procedures for sample handling, and conducted internal quality audits. In my Product Development role, I worked on converting discovery phase biomarkers for various diseases (osteoarthritis, bipolar disorder, and colorectal cancer) into RT-PCR based RNA expression assays, and on pre-clinical validation of these assays. Show less

In 1995 I became a consultant for Visible Genetics (Toronto) and continued in this capacity until I took full-time employment there in 1998, where I held positions of increasing responsibility (Senior Scientist, Development Manager, Director of Chemistry R&D). In 2001, Visible Genetics achieved FDA approval of its HIV-1 Genotyping Kit (BK020005), based in part on the work of my R&D Group. I next accepted a position as Director of Technology Transfer at Visible Genetics (Atlanta), where… Show more In 1995 I became a consultant for Visible Genetics (Toronto) and continued in this capacity until I took full-time employment there in 1998, where I held positions of increasing responsibility (Senior Scientist, Development Manager, Director of Chemistry R&D). In 2001, Visible Genetics achieved FDA approval of its HIV-1 Genotyping Kit (BK020005), based in part on the work of my R&D Group. I next accepted a position as Director of Technology Transfer at Visible Genetics (Atlanta), where I worked for 1 year on pilot-scale manufacturing, troubleshooting, and process validation for infectious disease assays (HIV-1, HBV) and genotyping assays (HLA). Show less

Located in Toronto. Principal Investigator in grants-funded research program, to study activation of cell-cycle checkpoints and apoptosis in early zebrafish embryo, as a model system for very early cancers. Responsibilities included writing grant proposals, maintaining an independent research program, writing peer-reviewed scientific papers, giving presentations at conferences, and supervising graduate and undergraduate students. Successfully developed 2 bioassays for genotoxic substances… Show more Located in Toronto. Principal Investigator in grants-funded research program, to study activation of cell-cycle checkpoints and apoptosis in early zebrafish embryo, as a model system for very early cancers. Responsibilities included writing grant proposals, maintaining an independent research program, writing peer-reviewed scientific papers, giving presentations at conferences, and supervising graduate and undergraduate students. Successfully developed 2 bioassays for genotoxic substances, using flattened whole mounts of zebrafish embryos. Show less

This NSF-funded center at Caltech, directed by Leroy Hood, was designed to be an interface between academia and industry. In this position I worked on technology for rapid, semi-automated genotyping by the oligonucleotide ligation assay (OLA). This work was later extended at Visible Genetics, to a patented technology (SLAM) for mutation scanning by multiple oligonucleotide ligation.